Humira. (adalimumab) Drug Update Slideshow NEW INDICATION

Transcription

1 Humira (adalimumab) NEW INDICATION Drug Update Slideshow

2 Introduction Brand name: Humira Generic name: Adalimumab Pharmacological class: Tumor necrosis factor (TNF) blocker Strength and Formulation: 10mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL; soln for SC inj; preservative-free Manufacturer: AbbVie How supplied: Single-dose prefilled syringe 2; Single-dose prefilled pen (40mg) 2, 4 (Starter Package) Legal Classification: Rx

3 HUMIRA

4 New Indication Non-infectious intermediate, posterior and panuveitis Also indicated for: Moderately-to-severely active rheumatoid arthritis Moderately-to-severely active polyarticular juvenile idiopathic arthritis Active psoriatic arthritis Active ankylosing spondylitis Moderately-to-severely active Crohn s disease Moderately-to-severely active ulcerative colitis Moderate-to-severe hidradenitis suppurativa Moderate-to-severe chronic plaque psoriasis

5 Dosage & Administration Uveitis Inject SC into thigh or abdomen; rotate inj sites; supervise 1 st dose 18yrs: initially 80mg, followed by 40mg every other week starting one week after initial dose For other indications, see full labeling

6 Considerations for Special Populations Pregnancy: Actively crosses placenta during 3 rd trimester; may affect immune response in in utero exposed infants Nursing mothers: Consider benefits and adverse effects Pediatric: <18yrs: not established Geriatric: Use caution (higher incidence of infections and malignancies)

7 Warnings/Precautions Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens) Active infections: do not initiate therapy Chronic or history of recurring infections Conditions that predispose to infection Travel to, or residence in, areas with endemic TB or mycoses

8 Warnings/Precautions Test/treat latent TB and HBV infection prior to initiating therapy Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops Lymphoma and other malignancies CHF (monitor) Immunosuppression

9 Warnings/Precautions Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero Latex allergy Elderly

10 Interactions Avoid live vaccines Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended Immunosuppressants increase risk of infection Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs

11 Adverse Reactions Inj site reactions Infections (may be serious) Headache Nausea Rash Abdominal pain Malignancies (eg, lymphoma: especially children) Blood dyscrasias Neurological events Antibody formation Lupus-like syndrome

12 Mechanism of Action Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors Adalimumab also lyses surface TNF expressing cells in vitro in the presence of a complement Adalimumab modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration

13 Clinical Trials The safety and efficacy of Humira were assessed in adults with non-infectious intermediate, posterior and panuveitis in 2 randomized, double-masked, placebocontrolled studies (UV I and II) Patients received placebo or Humira 80mg initially followed by 40mg every other week starting 1 week after the initial dose

14 Clinical Trials The primary efficacy endpoint in both studies was time to treatment failure, defined as: Development of new inflammatory chorioretinal and/or inflammatory retinal vascular lesions Increase in anterior chamber (AC) cell grade or vitreous haze (VH) Decrease in best corrected visual acuity (BCVA)

15 Clinical Trials UV I (n=217) evaluated patients with active uveitis while being treated with corticosteroids UV II (n=226) evaluated patients with inactive uveitis while being treated with corticosteroids Both studies demonstrated statistically significant reduction of risk of treatment failure in the Humira-treated group vs. placebo

16 Clinical Trials UV I Treatment failure was seen 78.5% of the placebo group vs. 54.5% of Humira group (HR 0.50, 95% CI: 0.36, 0.70) UV II Treatment failure was seen in 55.0% of the placebo group vs. 39.1% of the Humira group (HR 0.57, 95% CI: 0.39, 0.84) For more clinical data, see full labeling

17 Product Monograph For more information view the product monograph available at: